Blue Beacon Submucosal Injectable Solution
K-Number: K200071 · 2020-11-03
ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2020-11-03
Product CodePLL
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Blue Beacon Submucosal Injectable Solution is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2020-11-03 under approval number K200071. The device is classified under product code PLL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Blue Beacon Submucosal Injectable Solution?
Blue Beacon Submucosal Injectable Solution is a medical device that received FDA 510(k) clearance on 2020-11-03. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K200071.
When was Blue Beacon Submucosal Injectable Solution approved by the FDA?
Blue Beacon Submucosal Injectable Solution received FDA 510(k) clearance on 2020-11-03, under approval number K200071.
What company makes Blue Beacon Submucosal Injectable Solution?
Blue Beacon Submucosal Injectable Solution is manufactured by Micro-Tech (Nanjing) Co., Ltd..
What is the FDA product code for Blue Beacon Submucosal Injectable Solution?
The FDA product code for Blue Beacon Submucosal Injectable Solution is PLL.
Other Devices by Micro-Tech (Nanjing) Co., Ltd.
Related Devices (Code: PLL)
K180068ORISE GelBoston Scientific
K202376EverLift Submucosal Lifting AgentGi Supply, Inc.
K191923EverLift Submucosal Lifting AgentGi Supply
K191254EndoClotEndoclot Plus Co., Ltd.
K220434Blue Eye (TS-905)The Standard Co., Ltd.
K221385LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)Ovesco Endoscopy AG
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.